Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT07027033
Eligibility Criteria:
Inclusion Criteria:
* • Individual who has given informed consent.
* Female adult aged between 18 and 60 years (included).
* Patient with obesity at inclusion, meeting the HAS criteria for bariatric surgery eligibility: BMI ≥ 35 kg/m² associated with a comorbidity or BMI \> 40 kg/m².
* European origin: For this pilot study, we need to reduce variability factors and focus the research on women of European descent only (having both parents identified by the patient as of European origin).
* Effective contraception if sexually active, or abstinence, or menopause (criterion required for bariatric surgery).
* Presenting at inclusion with at least two clinical criteria of insulin resistance according to the definition of the International Diabetes Federation (IDF):
* Dysglycemia (fasting glucose ≥ 100 mg/dL, glucose intolerance, or type 2 diabetes).
* Hypertension (≥ 130/85 mm Hg).
* Low HDL-cholesterol (\< 50 mg/dL).
* Elevated triglycerides (≥ 150 mg/dL).
* Affiliated with a social security system or a beneficiary of such a system.
* Bariatric surgery performed at Nantes University Hospital (CHU de Nantes).
Exclusion Criteria:
* • Modification of diabetes treatment within the past month.
* Ongoing or planned insulin therapy before bariatric surgery.
* Modification of lipid-lowering treatment within the past three months.
* Systemic corticosteroid therapy.
* Antiviral therapy (HIV).
* Dietary supplementation affecting lipid metabolism, including proactive margarine, Danacol, polyunsaturated fatty acid supplementation, or any other substance identified by the investigator.
* Exocrine pancreatic insufficiency.
* Pregnancy or breastfeeding.
* History of organ transplantation.
* Individual deprived of liberty or under legal protection (guardianship or trusteeship).
* Any clinical condition in which the investigator considers that inclusion in the study may harm the patient's health or compromise the proper conduct of the study.
* Participation in other clinical trials, except for non-interventional studies and research on surgical techniques or postoperative strategies.
* Type I, monogenic or secondary diabetes.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07027033
Study Brief:
Protocol Section:
NCT07027033